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Ortho Solutions Sterile Drill Bits OS307205

by Ortho Solutions Holdings Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055662929126 UDI-DI Date20 Apr 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Ortho Solutions Sterile Drill Bits
Generic Name
Bone-resection orthopaedic reamer, reusable
Model / Ref / Catalog
OS307205
Primary DI / UDI-DI
05055662929126
510(k) Number
FDA Product Code
HWE
GMDN Term
Bone-resection orthopaedic reamer, reusable
Device Class
Class I
Regulation Number
878.4820
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-resection orthopaedic reamer, reusable

Cleared under the same submission (K102743)

Show all (12)

Other devices from Ortho Solutions Holdings Limited

See all devices from Ortho Solutions Holdings Limited →

Properties

  • Lot / Batch Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No